BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LeukoSure Enumeration Kit

    Reg #: 1017835 · FEI: 1017835 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BECKMAN COULTER, INC.
    Registration Number
    1017835
    FEI Number
    1017835
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    740 WEST 83RD ST.
    City
    HIALEAH
    State
    FL
    ZIP
    33014
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK020063

    Owner / Operator

    Firm Name
    BECKMAN COULTER, INC.
    Operator Number
    2050012
    Address
    250 S. Kraemer Blvd, --
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    David G Davis

    Products

    Device Name Product Code
    Kit, Quality Control For Blood Banking Reagents KSF

    Proprietary Names

    LeukoSure Enumeration Kit LeukoSure Fluorospheres

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)